Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
1. Patient is referred for assessment of recent hematuria, defined as either:
1. Microscopic hematuria (≥3 RBC/HPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR
2. Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with urine microscopy collected on the same day as enrollment
2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
3. Able to give informed, written consent.
4. Able and willing to comply with study requirements.
5. Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.
6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions.
You may not be if
1. Prior history of bladder malignancy.
2. Prior history of upper tract UC or prostatic urethral UC.
3. History of gross hematuria requiring instrumentation or hospitalization within the last 12 months
5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).
6. Cystoscopy contraindicated due to another condition or anatomy.
7. History of pelvic radiation.
8. Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks.
9. History of schistosomiasis.
10. History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
11. Known current pregnancy
Clareo Health | Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
